UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018876 |
|---|---|
| Receipt number | R000021831 |
| Scientific Title | Assessment of pulmonary endothelial function in pulmonary artery hypertension with the use of 123I-MIBG scintigraphy |
| Date of disclosure of the study information | 2015/09/20 |
| Last modified on | 2017/09/02 11:22:02 |
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Basic information
Public title
Assessment of pulmonary endothelial function in pulmonary artery hypertension with the use of 123I-MIBG scintigraphy
Acronym
123I-MIBG scintigraphy in pulmonary hypertension
Scientific Title
Assessment of pulmonary endothelial function in pulmonary artery hypertension with the use of 123I-MIBG scintigraphy
Scientific Title:Acronym
123I-MIBG scintigraphy in pulmonary hypertension
Region
| Japan |
Condition
Condition
Pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate pulmonary artery endothelial function by using 123I-MIBG scintigraphy
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine whether the lung 123I-MIBG uptake in the lung
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pulmonary hypertension
Key exclusion criteria
not have Parkinson disease, not have cardiac disease,not have pulmonary disease, and not have diabetes mellitus.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kayoko Tanaka |
Organization
Kagoshima University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
099-275-5318
kubota@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayoko Tanaka |
Organization
Kagoshima University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
099-275-5318
Homepage URL
kubota@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 15 | Day |
Other
Other related information
We analyzed the 123I-MIBG uptake in PH patients and compared it with the data obtained by echocardiography or right heart catheterization (RHC).
Management information
Registered date
| 2015 | Year | 09 | Month | 01 | Day |
Last modified on
| 2017 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021831
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
